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Healthy Skepticism Library item: 20442

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.


Publication type: Journal Article

Rodwin MA
Independent Clinical Trials to Test Drugs: The Neglected Reform
Saint Louis University Journal of Health Law & Policy 2012 Dec 24; 6:(12-58):113


Drug manufacturers face a fundamental conflict of interest. Pursuit of profit compromises their impartial assessment of their drugs’ benefits and risks. Their biased evaluation can corrupt public knowledge of drugs, lead to marketing unsafe and/or ineffective drugs, compromise medical practice and undermine rational physician prescribing. Over the last century, federal regulation has mitigated this problem through FDA regulation of clinical research used to support applications to market new drugs. Nevertheless, the conflicts of interest persist because the firm that seeks to market a drug designs and controls the clinical trials that the FDA relies upon when it decides whether or not to authorize marketing the drug. An ample record reveals that drug firms can design clinical trials in ways that bias the conclusions.

This article analyzes a reform proposal that precludes bias in clinical trials used to test drugs and compares its pros and cons to alternative regulatory strategies. The proposal would remove all drug firm influence on the design and conduct of clinical trials used to decide whether to allow marketing of a drug. In fact, between the late 1950s and 1980s, reformers and congressional leaders championed this idea, but pharmaceutical industry opposition blocked its enactment and so the federal government pursued alternative strategies, which have proved ineffective. By the mid-1990s, scandals prompted several leaders in drug policy and research to again advocate legislation to require independent drug testing. It would not be surprising if Congress opts for stricter regulation of clinical trials using the existing regulatory paradigm. However, to be effective, reforms need to eliminate the corruption that lies at the root: drug firm control over clinical trials.


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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909